Primary Lens Set, 28D, 90D, 3 Mirror

GUDID 00841668144268

KATENA PRODUCTS, INC.

Ophthalmic diagnostic condensing lens

• Primary Device ID: 00841668144268
• NIH Device Record Key: b8ac3e58-ffb2-4dba-8b1c-3fe1ba958796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primary Lens Set, 28D, 90D, 3 Mirror
• Version Model Number: K31-3002
• Company DUNS: 085668598
• Company Name: KATENA PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668144268 [Primary]

FDA Product Code

• HJL: Lens, condensing, diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-19
• Device Publish Date: 2024-04-11

Devices Manufactured by KATENA PRODUCTS, INC.

• 10841668123338 - KATENA: 2026-03-10 ROP Kit
• 10841668123949 - KATENA: 2026-03-10 Flat Vitrectomy Lens w fixed ring
• 10841668144463 - KATENA: 2026-03-10 High-Mag RS Lens
• 10841668144470 - KATENA: 2026-03-10 Wide-Angle Viewing RS Lens
• 10841668146474 - KATENA: 2026-03-10 Tonometer Prism
• 10841668146580 - Glaukos: 2026-01-23 IPRISMHF, GONIOPRISM
• 00841668144268 - Primary Lens Set, 28D, 90D, 3 Mirror: 2024-04-19
• 00841668144268 - Primary Lens Set, 28D, 90D, 3 Mirror: 2024-04-19
• 00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror: 2024-04-19